Quality indicators for the care and outcomes of adults with atrial fibrillation

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Europace (2020) 00, 1–17                                                                                              GUIDELINES
                                  doi:10.1093/europace/euaa253

Quality indicators for the care and outcomes of
adults with atrial fibrillation

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Task Force for the development of quality indicators in atrial
fibrillation of the European Heart Rhythm Association (EHRA) of
the European Society of Cardiology (ESC): Developed in
collaboration with the Heart Rhythm Society (HRS), the Asia Pacific
Heart Rhythm Society (APHRS), and the Latin-American Heart
Rhythm Society (LAHRS)

Elena Arbelo     (Chair)1*, Suleman Aktaa2, Andreas Bollmann3, André D’Avila4,
Inga Drossart5, Jeremy Dwight6, Mellanie True Hills7, Gerhard Hindricks3,
Fred M. Kusumoto8, Deirdre A. Lane9, Dennis H. Lau10, Maddalena Lettino11,
Gregory Y. H. Lip9, Trudie Lobban12, Hui-Nam Pak13, Tatjana Potpara14,
Luis C. Saenz15, Isabelle C. Van Gelder16, Paul Varosy17, Chris P. Gale2, and
Nikolaos Dagres3 (Co-chair)

Reviewers Serge Boveda18 (review coordinator), Thomas Deneke19, Pascal Defaye20, Giulio Conte21
Radoslaw Lenarczyk22, Rui Providencia23, Jose M. Guerra24, Yoshihide Takahashi25
Cristiano Pisani26, Santiago Nava27, Andrea Sarkozy28, Taya V. Glotzer29, Mario Martins Oliveira30
1
  Arrhythmia Section, Cardiology Department, Hospital Clı́nic, Universitat de Barcelona, C. Villarroel 170, Esc 3, Planta 6, 08036 Barcelona, Spain; Institut d’Investigació August Pi
i Sunyer (IDIBAPS), Barcelona, Spain; Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares (CIBERCV), Madrid, Spain; 2Leeds Institute for Data
Analytics, University of Leeds, UK; Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, UK; Department of Cardiology, Leeds Teaching Hospitals NHS
Trust, UK; 3Department of Electrophysiology, Heart Centre Leipzig at University of Leipzig, Leipzig, Germany; 4Cardiac Arrhythmia Service, Hospital SOS Cardio, Florianopolis,
SC, Brazil; Harvard-Thorndike Electrophysiology Institute, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA; 5European Society of Cardiology, Sophia
Antipolis, France; ESC Patient Forum, Sophia Antipolis, France; 6ESC Patient Forum, Sophia Antipolis, France; 7StopAfib.org, American Foundation for Women’s Health, Decatur,
TX, USA; 8Cardiology Department, Mayo Clinic Hospital, Jacksonville, FL, USA; 9Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart &
Chest Hospital, Liverpool, UK; Aalborg Thrombosis Research Unit, Department of Clinical Medicine, Aalborg University, Aalborg, Denmark; 10Centre for Heart Rhythm
Disorders, The University of Adelaide and Department of Cardiology, Royal Adelaide Hospital, Adelaide, South Australia, Australia; 11Cardiovascular Department, San Gerardo
Hospital, ASST-Monza, Monza, Italy; 12Arrhythmia Alliance/AF Association/STARS, Chipping Norton, UK; 13Yonsei University Health System, Seoul, Republic of Korea; 14School
of Medicine, University of Belgrade, Serbia; Cardiology Clinic, Clinical Centre of Serbia, Belgrade, Serbia; 15Fundación Cardio Infantil-Instituto de Cardiologı́a, Bogotá, Colombia;
16
   Department of Cardiology, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands; 17Rocky Mountain Regional Veterans Affairs Medical
Center and the University of Colorado Anschutz Medical Campus, Aurora, CO, USA; 18Clinique Pasteur, Heart Rhythm Department, 31076 Toulouse, France; 19Clinic for
Interventional Electrophysiology, Heart Centre RHÖN-KLINIKUM Campus Bad Neustadt, Germany; 20CHU Grenoble Alpes, Unite de Rythmologie Service De Cardiologie,
CS10135, 38043 Grenoble Cedex 09, France; 21Cardiology Department, Cardiocentro Ticino, Lugano, Switzerland; 22First Department of Cardiology and Angiology, Silesian
Centre for Heart Disease, Curie-Sklodowskiej Str 9, 41-800 Zabrze, Poland; 23St Bartholomew’s Hospital, Barts Heart Centre, Barts Health NHS Trust, London, UK and Institute
of Health Informatics, University College of London, London, UK; 24Department of Cardiology, Hospital de la Santa Creu i Sant Pau, Universidad Autonoma de Barcelona,
CIBERCV, Barcelona, Spain; 25Department of Advanced Arrhythmia Research, Tokyo Medical and Dental University, Tokyo, Japan; 26Heart Institute, Arrhythmia Unit, Sao Paulo,
Brazil; 27Head of Electrocardiology Department, Instituto Nacional de Cardiologia ‘Ignacio Chavez’, Mexico; 28University Hospital of Antwerp, University of Antwerp, Antwerp,
Belgium; 29Hackensack Meridian-Seton Hall School of Medicine, Rutgers New Jersey Medical School; Director of Cardiac Research, Hackensack University Medical Center,
Hackensack, USA; and 30Hospital Santa Marta, Department of Cardiology, Rua Santa Marta, 1167-024 Lisbon, Portugal

* Corresponding author. Tel: þ34 93 227 5551, Fax: þ34 93 451 3045, Email: elenaarbelo@secardiologia.es
Published on behalf of the European Society of Cardiology. All rights reserved. V
                                                                                C The Author(s) 2020. For permissions, please email: journals.permissions@oup.com
Page 2 of 17                                                                                                                                                                                                                                                                                                                                                                                   E. Arbelo et al.

Aims                                                                  To develop quality indicators (QIs) that may be used to evaluate the quality of care and outcomes for adults with
                                                                      atrial fibrillation (AF).
...................................................................................................................................................................................................
Methods                          We followed the ESC methodology for QI development. This methodology involved (i) the identification of the
and results                      domains of AF care for the diagnosis and management of AF (by a group of experts including members of the ESC
                                                                      Clinical Practice Guidelines Task Force for AF); (ii) the construction of candidate QIs (including a systematic review
                                                                      of the literature); and (iii) the selection of the final set of QIs (using a modified Delphi method). Six domains of
                                                                      care for the diagnosis and management of AF were identified: (i) Patient assessment (baseline and follow-up), (ii)

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                                                                      Anticoagulation therapy, (iii) Rate control strategy, (iv) Rhythm control strategy, (v) Risk factor management, and
                                                                      (vi) Outcomes measures, including patient-reported outcome measures (PROMs). In total, 17 main and 17 second-
                                                                      ary QIs, which covered all six domains of care for the diagnosis and management of AF, were selected. The out-
                                                                      come domain included measures on the consequences and treatment of AF, as well as PROMs.
...................................................................................................................................................................................................
Conclusion                       This document defines six domains of AF care (patient assessment, anticoagulation, rate control, rhythm control,
                                                                      risk factor management, and outcomes), and provides 17 main and 17 secondary QIs for the diagnosis and manage-
                                                                      ment of AF. It is anticipated that implementation of these QIs will improve the quality of AF care.
䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏 䊏

Keywords                         Atrial fibrillation • Quality indicators • Outcome measures
...........................................................................................................................................................................................

Abbreviations                                                                                                                                                                                                                 the quality of AF care.18–21,22 However, no AF quality indicators (QIs)
                                                                                                                                                                                                                              have been specifically designed for the wider international community.
AF     atrial fibrillation                                                                                                                                                                                                       Hence, the European Heart Rhythm Association (EHRA), in collabo-
EORP   EURObservational Research Programme                                                                                                                                                                                    ration with the Asian Pacific Heart Rhythm Society (APHRS), the
ESC    European Society of Cardiology                                                                                                                                                                                         Heart Rhythm Society (HRS), and the Latin-American Heart Rhythm
INR    international normalized ratio                                                                                                                                                                                         Society (LAHRS), established the AF QI Working Group, which was
LV     left ventricle                                                                                                                                                                                                         tasked with the development of QIs for the diagnosis and management
LVEF   left ventricular ejection fraction                                                                                                                                                                                     of adults with AF. It is hoped that these QIs can serve as a mechanism
PRISMA Preferred Reporting Items for Systematic Review and                                                                                                                                                                    to improve the quality of AF care, and be used by healthcare providers
       Meta-Analyses                                                                                                                                                                                                          to evaluate care delivery at the patient, centre, and national levels.
PROMs patient-reported outcome measures                                                                                                                                                                                          To enhance the translation of guideline recommendations into
PVs    pulmonary veins                                                                                                                                                                                                        clinical practice and give healthcare providers the tools to identify op-
QI     quality indicator                                                                                                                                                                                                      portunities for improvement, a summary of the AF QIs has been em-
QoL    quality of life                                                                                                                                                                                                        bedded in the 2020 ESC Clinical Practice Guidelines for AF.23 Efforts
RCT    randomized controlled trial                                                                                                                                                                                            were made to ensure alignment between the developed QIs and the
                                                                                                                                                                                                                              ESC Guidelines for AF, which may differ from recommendations de-
                                                                                                                                                                                                                              veloped by other professional organizations.

Introduction
Atrial fibrillation (AF) is a key public health challenge and a major                                                                                                                                                         Methods
source of morbidity, mortality, and economic burden for govern-                                                                                                                                                               The detailed methodology for the development of QIs for the quantifica-
ments worldwide.1 Despite progress in the management of patients                                                                                                                                                              tion of cardiovascular care and outcomes for the ESC Clinical Practice
with AF, this arrhythmia is still a major cause of stroke, heart failure,                                                                                                                                                     Guidelines is published separately.24 This methodology consists of a four-
and cardiovascular morbidity and mortality globally.2 Additionally, AF                                                                                                                                                        step process: identification of the key domains of care; construction of
is associated with cognitive impairment,3–5 reduced quality of life                                                                                                                                                           candidate indicators; selection of a final QI set; and undertaking of a feasi-
(QoL),6,7 depression,8 and frequent hospital admissions.9–11 The                                                                                                                                                              bility assessment. In this document, we have identified important domains
magnitude of the economic burden of AF is increasing, mainly driven                                                                                                                                                           of AF care, and developed QIs for each domain. The development pro-
by AF-related complications and management costs, particularly                                                                                                                                                                cess involved conducting a systematic review of the literature, and using a
                                                                                                                                                                                                                              modified Delphi method25 to derive the final set of QIs and divide them
those associated with hospitalizations.2,12,13
                                                                                                                                                                                                                              into main and secondary QIs. The next step would be to conduct a feasi-
   Data from the EURObservational Research Programme in AF
                                                                                                                                                                                                                              bility assessment of the developed QIs using existing AF registries.24
(EORP-AF) found that adherence to guideline-recommended thera-
                                                                                                                                                                                                                                  Quality indicators may be divided into structural, process, and out-
pies in the treatment of AF is associated with lower mortality,14 yet                                                                                                                                                         come indicators.26 For each proposed QI, we provided relevant specifica-
large variability persists in the delivery of such therapies across                                                                                                                                                           tions, including numerator, denominator, measurement period, and
Europe.15,16 To improve the implementation of evidence-based medi-                                                                                                                                                            measurement duration. However, no care settings were suggested, be-
cine,17 some professional organizations have developed quality stand-                                                                                                                                                         cause the proposed QIs are applicable in both the inpatient and outpa-
ards, clinical indicators, and quality measures to evaluate and improve                                                                                                                                                       tient care. It is, thus, important to determine locally the clinical setting
Quality indicators for the care and outcomes of adults with atrial fibrillation                                                               Page 3 of 17

during which QIs are applied in order to ensure the same processes of             Excel spreadsheet. When available, the following information was
care are evaluated between healthcare providers.                                  obtained for the extracted QIs: definition (including numerator, denomina-
                                                                                  tor, and exclusions), objective, type of QI (structural, process, outcome,
Members of the Working Group                                                      or PROM), domain of application, and potential data collection source.
The Working Group comprised members of the ECG Clinical Practice
Guidelines Task Force, as well as international experts in AF manage-             Clinical practice guidelines and existing QIs
ment, patients with AF, and representatives from patient organizations.           In addition to the systematic review outlined earlier, we reviewed relevant
Six domains of AF care were defined: (i) Patient assessment (baseline and

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                                                                                  clinical practice guidelines and existing QIs from different professional
follow-up), (ii) Anticoagulation therapy, (iii) Rate control strategy,            organizations (Table 1). The goal of the clinical practice guidelines review
(iv) Rhythm control strategy, (v) Risk factor management, and (vi)                was to identify the recommendations with the strongest association with
Outcomes measures, including patient-reported outcome measures                    benefit or harm and to assess these recommendations against the ESC cri-
(PROMs). The names, affiliations, and conflicts of interest of the AF QIs         teria for QIs (Table 2).24 Additionally, existing publications on QIs for
Working Group are provided in Supplementary material, Appendix 1.                 patients with AF were also reviewed and, when applicable, information
                                                                                  about the feasibility and/or validity of these measures was obtained.
Systematic review
Search strategy                                                                   Data synthesis
We conducted a systematic review of the published literature in accor-            Candidate QIs
dance with the Preferred Reporting Items for Systematic Review and                A list of candidate QIs was derived from the aforementioned systematic
Meta-Analyses (PRISMA) statement27,28 (Supplementary material,                    review and classified into structural, process, or outcome measures
Appendix 2). We searched two online bibliographic databases: MEDLINE              depending on the aspect of care being measured26. For each QI, a de-
                         R
and Embase via OVIDV. The initial search strategy was developed in                tailed definition was provided in order to facilitate the evaluation process.
MEDLINE using keywords and, when available, Medical Subject Headings
(MesH) based on three main terms: ‘atrial fibrillation’, ‘quality indicators’,
and ‘outcome measures’ (Supplementary material, Appendix 3). The final            Modified Delphi process
search strategies were then developed using an iterative process, which           We used the modified Delphi process25, 29 to evaluate the candidate QIs
also included citations search, grey literature, and a hand search of the ref-    and arrive at the final set of QIs. Instructions on the voting process, includ-
erence lists of the selected studies.                                             ing QIs criteria (Table 2) were sent to the Working Group before the vote.
    We included randomized controlled trials (RCTs) and observational             All measures were independently graded by each member of the Group
studies, including local, national, and international registries. We excluded     using the SurveyMonkey platform. Three rounds of voting were conducted,
systematic reviews, meta-analyses, editorial letters, and conference pro-         with a teleconference after each round to discuss the results of the vote. In
ceedings. We only included the main publications of major trials and reg-         the first voting round, we used a 9-point ordinal scale, where ratings of 1 to
istries from which our search obtained only their sub-studies. The search         3 signified that the QI was not valid; ratings of 4 to 6 meant that the QI was
was restricted to full-text articles published in the English language with a     of uncertain validity; and ratings of 7 to 9 indicated that the QI was valid.
publication date between 1 January 2014 and 5 October 2019, to capture            Candidate QIs were included if >_75% of the Working Group members
QIs and outcome measures for AF from contemporary practice.                       ranked them between 7 and 9, and were excluded if >_75% of the Working
                                                                                  Group members ranked them between 1 and 3. Indicators that did not fall
                                                                                  in the two categories above were carried forward to the second voting
Eligibility criteria                                                              round, where a 3-point scale (should not be included, maybe, and should
We included articles that fulfilled the following criteria: (i) the study popu-   be included) was implemented, but the same percentage agreement (>_75%
lation was adult patients (>_18 years old) with AF, (ii) the study explicitly     of the Working Group members) cut-off was used. The final round com-
stated at least one QI or outcome measure to define best practice for AF          prised a binary, ‘yes’ or ‘no’ questionnaire to obtain the Working Group
diagnosis and/or management, (iii) the study provided specifications for          members’ agreement on the proposed final set of QIs.
the QI or outcome measure (e.g. definition, data collection source,
method of reporting), (iv) RCT or registry, and (v) full-text publication.
No restrictions were applied to the presence of, or the type of, interven-
tion or comparison in the study.
                                                                                  Results
                                                                                  Search results
Study selection                                                                   The literature search retrieved 2954 articles, of which 441 met the in-
A reference manager software (Zotero) was used for duplicates removal
                                                                                  clusion criteria (Figure 1). These articles were used to extract a total of
and data management. Two authors (Suleman Aktaa and Elena Arbelo) in-
                                                                                  352 candidate QIs (17 related to structure, 162 to process, and 173 re-
dependently examined the abstracts of the studies retrieved from the
search against the inclusion criteria. Disagreements were resolved through        lated to outcomes) before the first voting round. Of these 34 QIs (19
discussion and review of the full text of the article when required.              related to process and 15 related to outcomes) were selected by the
                                                                                  end of the second round (Table 3). Over 93% of the Working Group
                                                                                  members agreed on this final set of QIs in the third voting round.
Data extraction
                                                                                     The domains for AF care identified by the Working Group were:
The full texts of the included studies were independently reviewed by two
authors (Suleman Aktaa and Elena Arbelo). All QIs relevant to the agreed          (i) Patient assessment (baseline and follow-up), (ii) Anticoagulation
six domains of AF care, namely: (i) Patient assessment (baseline and              therapy, (iii) Rate control strategy, (iv) Rhythm control strategy, (v)
follow-up), (ii) Anticoagulation therapy, (iii) Rate control strategy,            Risk factor management, and (vi) Outcome measures (including
(iv) Rhythm control strategy, (v) Risk factor management, and (vi)                PROMs). For each domain, main, and for some secondary, QIs have
Outcomes measures (including PROMs) were extracted and listed on an               been developed. Figure 2 shows the main QIs according to their
Page 4 of 17                                                                                                                                                                                        E. Arbelo et al.

 Table 1 Existing clinical practice guidelines and QIs used during the development process

  Organization                                                                                               Type                                                  Year                    Country/Region
  ....................................................................................................................................................................................................................
  ESC Guideline for the management of patients with atrial                                                   Clinical Practice Guidelines                          2020                    Europe
  fibrillation23
  ICHOM international standard set of outcome measures for                                                   QIs                                                   2020                    Worldwide
  patients with atrial fibrillation134

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  AHA/ACC/HRS focused update of the 2014 AHA/ACC/HRS                                                         Clinical Gractice Guidelines                          2019                    United States
  Guideline for the management of patients with atrial fibrillation31
  Canadian quality indicators for atrial fibrillation and atrial flutter20                                   QIs                                                   2019                    Canada
  Harmonized outcome measures for use in atrial fibrillation patient                                         QIs                                                   2019                    United States
  registries and clinical practice154
  ACC/AHA clinical performance and quality measures for adults                                               QIs                                                   2016                    United States
  with atrial fibrillation or atrial flutter18
  ESC Guidelines for the management of atrial fibrillation                                                   Clinical Practice Guidelines                          2016                    Europe
  developed2
  NICE atrial fibrillation quality standard21                                                                QIs                                                   2015                    United Kingdom
  AHA/ACC/HRS Guidelines for the management of patients with                                                 Clinical Practice Guidelines                          2014                    United States
  atrial fibrillation30

 QI, quality indicators; AHA, American Heart Association; ACC, American College of Cardiology; ESC, European Society of Cardiology; ICHOM, International Consortium for
 Health Outcomes Measurement; NICE, National Institute for Care and Health Excellence.

 Table 2 Criteria for the development and evaluation of the ESC quality indicators for cardiovascular disease

  Domain                             Criteria
  ....................................................................................................................................................................................................................
  Importance                         QI reflects a clinical area that is of high importance (e.g. common, major cause for morbidity, mortality, and/or health-related
                                     quality of life impairment).
                                     QI relates to an area where there are diparities or suboptimal care.
                                     QI implementation will result in an improvement in patient outcomes.
                                     QI may address appropriateness of medical interventions.
  ....................................................................................................................................................................................................................
  Evidence base                      QI is based on an acceptable evidence consistent with contemporary knowledge.
                                     QI aligns with the respective ESC Clinical Practice Guideline recommendations.
  ....................................................................................................................................................................................................................
  Specification                      QI has a clearly defined patient group to whom the measurement applies (denominator), including explicit exclusions.
                                     QI has clearly defined accomplishment criteria (numerator).
  ....................................................................................................................................................................................................................
  Validity                           QI is able to correctly assess what it is intended to, adequately distinguishes between good and poor quality of care, and com-
                                     pliance with the indicator would confer health benefits.
  ....................................................................................................................................................................................................................
  Reliability                        QI is reproducible even when data is extracted by different people, and estimates of performance on the basis of available data
                                     are likely to be reliable and unbiased.
  ....................................................................................................................................................................................................................
  Feasibility                        QI may be identified and implemented with reasonable cost and effort.
                                     Data needed for the assessment is (or should be) readily available and easily extracted within an acceptable time frame.
  ....................................................................................................................................................................................................................
  Interpretability                   QI is interpretable by healthcare providers, so that practitioners can understand the results of the assessment and take actions
                                     accordingly.
  ....................................................................................................................................................................................................................
  Actionability                      QI is influential to the current practice, where a large proportion of the determinants of adherence to the QI, are under the
                                     control of healthcare providers.
                                     This influence of QI on behaviour will likely improve care delivery.
                                     QI is unlikely to cause negative unintended consequences.

 QI, quality indicator.
Quality indicators for the care and outcomes of adults with atrial fibrillation                                                              Page 5 of 17

                                Records idenfied through                          Addional records idenfied
      Idenficaon
                                   database searching                               through other sources
                                       (n = 2954)                                           (n = 9)

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                                                    Records aer duplicates removed
                                                              (n = 2318)
      Screening

                                                             Records screened                             Records excluded
                                                                (n = 2318)                                  (n = 1162)*
      Eligibility

                                                         Full-text arcles assessed                   Full-text arcles excluded
                                                                for eligibility                               (n = 766)**
                                                                 (n = 1156)
      Included

                                                            Studies included in
                                                           qualitave synthesis
                                                                 (n = 441)

      *Records excluded:
               •Not populaon of interest (825): unrelated to cardiovascular disease (266), stroke (113), hearailure/congenital (81),
               cardiovascular surgery (69), other arrhythmias (55), coronary artery disease (50), cardiovascular risk factors (35), valvular heart
               disease (29), cardiovascular disease general (20), other (107)
               •Study type (274): abstract (201), study protocol (22), non-systemac review (20), systemac-review/meta-analysis (7),
               leer/note/survey (11), cost-effecveness analysis (5), editorial (4), basic research (4).
               •Sub-studies of main publicaons (53)
               •Other (10)
      **Full text arcles excluded due to the lack of clear definions and/or specificaons of the quality indicators and/or outcome measures.

  Figure 1 PRISMA flow diagram for selection of included studies.

respective domain of care. The full set of main and secondary QIs,
                                                                                    01MQI1: Proportion of patients with cardio-embolic risk as-
alongside their definitions, proposed measurement period (the time
                                                                                    sessment using CHA2DS2-VASc score
point at which the assessment is performed), measurement duration
                                                                                    Numerator: Number of patients with AF who have their CHA2DS2-
(the time frame needed for enough cases to be collected), and when
                                                                                    VASc score documented at the time of diagnosis and at every follow-up
applicable, the corresponding ESC Clinical Practice Guidelines rec-
                                                                                    appointment.
ommendations are illustrated in APPENDIX 4. For each QI, a unique
                                                                                    Denominator: Number of patients with AF.
code was developed using the domain number and indicating
                                                                                    01MQI2: Proportion of patients with bleeding risk assessment
whether the QI is main or secondary.
                                                                                    using a validated method, such as the HAS-BLED score
                                                                                    Numerator: Number of patients with AF who have their bleeding risk
Quality indicators                                                                  assessment documented at the time of diagnosis and at every follow-up
Domain 1: Patient assessment (baseline and follow-up)                               appointment using a validated bleeding risk score.
Stroke prevention is the cornerstone of the AF patient management                   Denominator: Number of patients with AF.
pathway, and ‘avoid stroke/anticoagulation’ is the ‘A’ of the ABC                   01MQI3: Proportion of patients with a measurement of their
pathway32, within the 2020 ESC guidelines23.                                        serum creatinine (or creatinine clearance)
   Stroke risk in AF is not homogeneous and depends on the pres-                    Numerator: Number of patients with AF who have their serum creatinine
ence of various stroke risk factors33. The CHA2DS2-VASc score is                    checked at the time of diagnosis and at every follow-up appointment.
recommended to assess stroke risk where the default should be to                    Denominator: Number of patients with AF.
offer stroke prevention, unless the patient is low risk; hence use the
Page 6 of 17                                                                                                                                                                                        E. Arbelo et al.

 Table 3 Primary (green) and secondary (yellow) quality indicators for AF diagnosis and management

  Code                           Quality indicators
  ....................................................................................................................................................................................................................
                                 Domain 01: Patient assessment (at baseline and follow-up)
  01MQI1                         Proportion of patients with cardio-embolic risk assessment using CHA2DS2-VASc score
  01MQI2                         Proportion of patients with bleeding risk assessment using a validated method, such as the HAS-BLED score
  01MQI3                         Proportion of patients with a measurement of their serum creatinine (or creatinine clearance)

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  01SQI1                         Proportion of people >_65 years of age with risk factors for AF who have pulse check
  01SQI2                         Proportion of patients with AHREs detected on implantable cardiac devices who undergo further cardiovascular evaluation
  01SQI3                         Proportion of cryptogenic stroke patients who have been screened for AF
  01SQI4                         Proportion of patients with an ECG documentation of AF
  01SQI5                         Proportion of patients who have been engaged in shared decision making when deciding treatment strategy
                                 Domain 02: Anticoagulation
  02MQI1                         Proportion of patients who are appropriately prescribed anticoagulation according to CHA2DS2-VASc score*
  02MQI2                         Proportion of patients with a CHA2DS2-VASc score of 0 for men and 1 for women who are inappropriately prescribed long-term
                                 anticoagulation
  02MQI3                         Proportion of patients with ‘appropriate anticoagulation’ at every follow-up visit, defined as:
                                       c. TTR**>_70% for vitamin-K antagonist.
                                       d. Appropriate dose for NOAC according to manufacturer recommendations.
                                 Domain 03: Rate control
  03MQI1                         Proportion of patients with permanent AF (i.e. where no attempt to restore sinus rhythm is planned), who are inappropriately
                                 prescribed antiarrhythmic drugs
  03SQI1                         Proportion of patients with LVEF_75 years, Diabetes mellitus, Stroke, Vascular disease, Age 65–74 years,
 Sex category (female); ECG, electrocardiogram; HAS-BLED, Hypertension, Abnormal renal/liver function, Stroke, Bleeding history or predisposition, Labile INR, Elderly (>65 years),
 Drugs/alcohol concomitantly; LVEF, left ventricular ejection fraction; NOAC, non-vitamin K antagonist oral anticoagulants; PVs, pulmonary veins; TTR, time in therapeutic range.
 *Appropriateness of anticoagulation prescription is defined as CHA2DS2-VASc score of >_1 for men and >_2 for women in the 2020 ESC Guidelines23. The 2014 ACC/AHA
 Guidelines (and 2019 focused update) define anticoagulation prescription appropriateness and CHA2DS2-VASc score of >_2 for men and >_3 for women30,31.
 **TTR calculated using Rosendaal method.
 ***Crude and risk-adjusted rates (risk adjustment should, as a minimum, consider age, sex, and comorbidities).
Quality indicators for the care and outcomes of adults with atrial fibrillation                                                            Page 7 of 17

                                                                 1. Patient assessment
                                                                    CHA2DS2-VASc
                                                                     Bleeding risk

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                                                                    Serum creatnine

                    5. Risk factor
                    management                                                                                        2. Anticoagulation
                Modifiable risk factor                                                                            OAC prescribed for high
               identification, including                                                                             CHA2DS2-VASc
              blood pressure, obesity,                                                                             Inappropriate OAC for
                   obstructive sleep                             6. Outcome measures                                low CHA2DS2-VASc
              apnoea, alcohol excess,
                                                                   All cause morality                             TTR ≥70% / appropriate
                lack of exercise, poor
                                                                 Ischaemic stroke / TIA                                NOAC dose
                glycaemic control and
                        smoking                                 Life-threatening / major
                                                                        bleeding
                                                                Procedure-related death
                                                                Procedure-/drug-related
                                                                serious adverse events
                                                                         HRQoL

                                      4. Rhythm control
                                    Inappropriate use of
                                       class IC AAD in
                                  structural heart disease
                                    Inappropriate use of                                            3. Rate control
                                     dofetilide/sotalol in                                       Inappropriate AAD in
                                      ESRD or dialysis                                              permanent AF
                                      CA for symptomatic
                                     paroxysmal/persistent
                                     AF after one class I or
                                         class III AAD

  Figure 2 Domains of AF care with their respective main quality indicators. AAD, antiarrhythmic drug; AF, atrial fibrillation; CA, catheter ablation;
  ESRD, end-stage renal disease; HRQoL, health-related quality of life; NOAC, non-vitamin K antagonist oral anticoagulant; OAC, oral anticoagulants;
  TTR, time in therapeutic range; TIA, transient ischaemic attack.

CHA2DS2-VASc score to initially define low risk patients (CHA2DS2-                Based on a Patient-Centered Outcomes Research Institute (PCORI)
VASc score 0 in males, 1 in females) who do not need antithrombotic               systematic review and evidence appraisal, the best validated bleeding
therapy (indicator 01MQI1). The subsequent step is to offer stroke                risk score is the HAS-BLED score36 . While stroke and bleeding risks
prevention in those with 1 or more risk factors (CHA2DS2-VASc                     track each other, the evidence shows that a formal bleeding risk
score >_1 in males, >_2 in females). Since stroke risk is dynamic, and            score (HAS-BLED) is superior to stroke risk scores (e.g. CHADS2,
influenced by ageing and incident risk factors, risk reassessment                 CHA2DS2-VASc) for assessing bleeding risk37,38. A strategy for dy-
should occur at every follow-up visit34.                                          namic bleeding risk assessment using the HAS-BLED score has been
   Bleeding risk changes over time as well and should also be assessed            shown to reduce bleeding risk and to increase oral anticoagulation
at every patient contact, initially to identify modifiable bleeding risks         (OAC) use39.
that should be mitigated, and to identify the ‘high bleeding risk’ patient           Given that renal function has implications for both stroke and bleeding
who should be scheduled for early follow-up35 (indicator 01MQI2).                 risk40, as well as prescriptions of OAC (choice of agent and dose),
Page 8 of 17                                                                                                                            E. Arbelo et al.

                                                                             However, screening for AF should be accompanied by confirming
01SQI1: Proportion of people 65 years of age with risk factors
                                                                          the diagnosis by traditional means, such as by 12-lead ECG or >30 s
for AF who have pulse check
                                                                          recording of a single-lead ECG, Holter monitor, or event recorder
Numerator: Number of people >_65 years of age with risk factors for AF
                                                                          (indicator 01SQI4). Following the diagnosis, a dialogue between
who have a documentation of pulse check (or ECG) to identify rhythm.
                                                                          treating physician and patient to ensure patient involvement in deci-
Denominator: Number of people >_65 years of age with risk factors for
                                                                          sion making is recommended23,54 . Thus, the indicator 01SQI5 cap-
AF.
                                                                          tures shared decision making when deciding on the treatment
01SQI2: Proportion of patients with atrial high-rate episodes

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                                                                          strategy.
(AHREs) detected on implantable cardiac devices who undergo
further cardiovascular evaluation
Numerator: Number of patients with AHREs detected on implantable          Domain 2: Anticoagulation
cardiac devices who have documentation of complete cardiovascular         Oral anticoagulation is an essential part of AF management, and the
evaluation.                                                               ESC 2020 Guidelines recommend oral anticoagulation for stroke pre-
Denominator: Number of patients with atrial high-rate episodes            vention in males with CHA2DS2-VASc scores of >_1, and in females
detected on implantable cardiac devices.                                  with scores of >_223. Accordingly, it is important that a set of QIs to
01SQI3: Proportion of cryptogenic stroke patients who have                regularly assess the proportion of patients with CHA2DS2-VASc score
been screened for AF                                                      >_1 in males, >_2 in females who are offered stroke prevention (indica-
Numerator: Number of patients with cryptogenic stroke* who have           tor 02MQI1), as well as the inappropriate use of long-term antithrom-
documentation of AF screening using continuous ECG recording.             botic therapy in low risk patients (CHA2DS2-VASc score 0 in males,
Denominator: Number of patients with cryptogenic stroke with no pre-      and 1 in females) (indicator 02MQI2).
vious history of AF.                                                         Assessment of the quality of anticoagulation is also important. If
01SQI4: Proportion of patients with an ECG documentation of               patients are taking a non-vitamin K antagonist oral anticoagulant
AF                                                                        (NOAC), the label-adherent dose of the respective NOAC should
Numerator: Number of AF patients with documentation of an ECG
confirming AF diagnosis.                                                  02MQI1: Proportion of patients who are appropriately pre-
Denominator: Number of AF patients.                                       scribed anticoagulation according to CHA2DS2-VASc score**
01SQI5: Proportion of patients who have been engaged in                   Numerator: Number of patients with AF who have CHA2DS2-VASc
shared decision making when deciding treatment strategy                   score of >_1 for men and >_2 for women and are prescribed anticoagula-
Numerator: Number of AF patients with a documentation of patient en-      tion for AF.**
gagement when deciding treatment strategy.                                Denominator: Number of patients with AF who have CHA2DS2-VASc
Denominator: Number of AF patients.                                       score of >_1 for men and >_2 for women and are eligible for anticoagula-
                                                                          tion, with no contraindication or refusal.**
                                                                          02MQI2: Proportion of patients with a CHA2DS2-VASc score of
                                                                          0 for men and 1 for women who are inappropriately prescribed
regular measurements of serum creatinine or creatinine clearance (based   long-term anticoagulation
on the Cockcroft-Gault formula) are needed, the frequency of which is     Numerator: Number of patients with AF who have CHA2DS2-VASc
determined by the renal function at baseline41 (indicator 01MQI3).        score of 0 for men and 1 for women and are inappropriately prescribed
    Asymptomatic AF is associated with a higher risk of stroke and mor-   long-term anticoagulation for AF.
tality compared with symptomatic AF. An observational study indi-         Denominator: Number of patients with AF who have CHA2DS2-VASc
cated that the application of standard care treatments for subclinical    score of 0 for men and 1 for women and do not have other indication for
AF detected on screening improves outcomes45,, and a systematic re-       anticoagulation.
view and economic analysis suggested that screening programmes for        02MQI3: Proportion of patients with ‘appropriate anticoagula-
AF are likely to represent a cost-effective use of resources46,. Thus,    tion’ at every follow-up visit, defined as:
screening for AF amongst people >_65 years of age by checking their         a. Time in therapeutic range TTR70% for vitamin-K
pulse may have therapeutic implications as these individuals need to be        antagonist.
considered for thromboprophylaxis (indicator 01SQI1).                       b. Appropriate dose for NOAC according to manufacturer
    To that end, atrial high-rate episodes (AHRE) detected by                 recommendations.***
implanted cardiac devices, which may represent asymptomatic AF,           Numerator: Number of patients with AF who have appropriate anticoa-
should be investigated47,48. Ideally, AHRE detection should be            gulation defined as TTR>_70% for vitamin-K antagonist, and appropriate
performed at every device interrogation, including home monitor-          dose for NOAC according to manufacturer recommendations.***
ing transmission as it determines whether or not subclinical AF is        Denominator: Number of patients with AF on anticoagulation.
confirmed and whether anticoagulation and/or regular follow-up
is warranted23 (indicator 01SQI2). Furthermore, the detection of           **Appropriateness of anticoagulation prescription is defined as CHA2DS2-VASc
                                                                           score of >_1 for men and >_2 for women in the 2020 ESC Guidelines. The 2014
previously unknown AF following a stroke has relevant implica-             ACC/AHA Guidelines (and 2019 focused update) define anticoagulation pre-
tions for secondary prevention49,50. Thus, it is recommended to            scription appropriateness and CHA2DS2-VASc score of >_2 for men and >_3 for
screen for AF following a cryptogenic stroke 2352–54 (indicator            women.23,30,31
                                                                           ***Manufacturer recommendations are defined in APPENDIX 5.
01SQI3).
Quality indicators for the care and outcomes of adults with atrial fibrillation                                                               Page 9 of 17

be prescribed and the proportion appropriately dosed is indicative of
                                                                                  04MQI1: Proportion of patients with structural heart disease
quality of care. Regular audits should be performed to ensure that un-
                                                                                  who are inappropriately prescribed class IC antiarrhythmic
der- or over-dosing of the respective NOAC does not occur, given
                                                                                  drugs
the association with worse outcomes55–57 (indicator 02MQI3). Oral
                                                                                  Numerator: Number of patients with AF who have structural heart dis-
anticoagulation can also be offered as a well-managed vitamin K an-
                                                                                  ease and are inappropriately prescribed class IC antiarrhythmic drugs.
tagonist (VKA) (e.g. warfarin, acenocoumarol, phenprocoumon, etc.),
                                                                                  Denominator: Number of patients with AF who have structural heart
with a high (>_70%) time in therapeutic range (TTR) calculated using
                                                                                  disease.

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the Rosendaal method, with international normalized ratio (INR)
                                                                                  04MQI2: Proportion of patients with end-stage kidney disease
2.0–3.0. High TTR has been associated with low rates of stroke and
                                                                                  who are inappropriately prescribed dofetilide or sotalol
bleeding, as well as reduced mortality58–60. Thus, the proportion of
                                                                                  Numerator: Number of patients with AF who have end-stage kidney disease
patients with TTR >_ 70% is a good QI of anticoagulation control for
                                                                                  and/or on dialysis$$ and are inappropriately prescribed dofetilide or sotalol.
patients on VKA.
                                                                                  Denominator: Number of patients with AF who have end-stage kidney
                                                                                  disease, including patients on dialysis.
                                                                                  04MQI3: Proportion of patients with symptomatic paroxysmal
                                                                                  or persistent AF who are offered AF catheter ablation after
Domain 3: Rate control
                                                                                  failure of, or intolerance to, one class I or class III antiarrhyth-
Rate control is an integral part of AF management, and may be suffi-
                                                                                  mic drug
cient to improve AF-related symptoms61. In patients for whom a de-
                                                                                  Numerator: Number of patients with paroxysmal or persistent AF who
cision has been made not to restore or maintain sinus rhythm
                                                                                  are offered catheter ablation after the failure of, or intolerance to, one
(permanent AF), rate control can be achieved by rate-limiting medi-
                                                                                  class I or class III antiarrhythmic drug.
cations (e.g. beta-blockers, digoxin, diltiazem, or verapamil). The use
                                                                                  Denominator: Number of patients with paroxysmal or persistent AF with no
of antiarrhythmic drugs, such as amiodarone, dronedarone, or sotalol
                                                                                  contraindications (or refusal) to catheter ablation who remain symptomatic on,
for rate control is not recommended when no attempt to restore si-
                                                                                  or intolerant to, one class I or class III antiarrhythmic drug.
nus rhythm is planned62–65 (indicator 03MQI1).
   The use of certain types of rate control drugs, such as non-
dihydropyridine calcium-channel blockers can influence outcomes in
patients with heart failure and/or left ventricular ejection fraction
(LVEF) of
Page 10 of 17                                                                                                                                E. Arbelo et al.

   A QI to assess the complete electrical isolation (entrance and exit
                                                                             06.1MQI1: Annual rate of all-cause mortality*
block) of the pulmonary veins (PVs) during AF catheter ablation pro-
                                                                             Numerator: Number of patients with AF who died during the measure-
cedures (indicator 04SQI1) was developed given that this is the de-
                                                                             ment duration.
sired outcome of AF ablation69,73,74,88–99. In addition, the indicator
                                                                             Denominator: Number of patients with AF.
04SQI2 assesses the consideration of cardioversion for patients with
                                                                             06.1MQI2: Annual rate of ischaemic stroke or transient ischae-
new-onset persistent AF.
                                                                             mic attack*
                                                                             Numerator: Number of patients with AF who had documented ischae-

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                                                                             mic stroke or transient ischaemic attack during the measurement
Domain 5: Risk factor management
                                                                             duration.
The Working Group considered the role of risk factors in AF and
                                                                             Denominator: Number of patients with AF.
developed a QI accordingly (indicator 05MQI1). Recent research
has highlighted the potential benefits of risk factor management as           *Crude and risk-adjusted rates (risk adjustment should, as a minimum, consider
upstream non-invasive therapy to lower the risk of AF progres-                age, sex, and comorbidities.

sion and recurrence100–106. A large proportion of these risk fac-
tors are lifestyle related and, therefore, are amenable to be
targeted and modified107. It is recommended that in the assess-
ment of AF patients, practitioners actively evaluate and document            06.1SQI1: Annual rate of cardiovascular mortality*
these modifiable risk factors, such as smoking, obesity100,102,108,          Numerator: Number of patients with AF who died from cardiovascular
physical inactivity109–111, alcohol intake105,112–114, sleep115 ap-          cause during the measurement duration.
noea116,117, hypertension115,118,119, and poor glycaemic con-                Denominator: Number of patients with AF.
trol120. Where necessary, appropriate education, support, and                06.1SQI2: Annual rate of cardiovascular hospitalization*
intervention (e.g. smoking cessation options, continuous positive            Numerator: Number of patients with AF who had unplanned hospitaliza-
airway pressure (CPAP), exercise prescription, etc.) can be pro-             tion for a cardiovascular cause during the measurement duration.
vided to the patient to address the risk factors that may improve            Denominator: Number of patients with AF.
health outcomes.                                                             06.1SQI3: Annual rate of overall thromboembolic events*
                                                                             Numerator: Number of documented AF-related thrombo-embolic
                                                                             events during the measurement duration.
05MQI1: Proportion of patients who have their modifiable risk
                                                                             Denominator: Number of patients with AF.
factors identified
                                                                             06.1SQI4: Annual rate of clinician-reported symptom status
Numerator: Number of patients with AF who have their modifiable risk
                                                                             assessment
factors (e.g. blood pressure, obesity, obstructive sleep apnoea, alcohol
                                                                             Numerator: Number of patients with AF who had their clinician-
excess, lack of exercise, poor glycaemic control, and smoking) identified.
                                                                             reported symptom status assessed using a validated tool (e.g. EHRA
Denominator: Number of patients with AF.
                                                                             symptom score) during the measurement duration.
                                                                             Denominator: Number of patients with AF.

                                                                              *Crude and risk-adjusted rates (risk adjustment should, as a minimum, consider
Domain 6: Outcome measures                                                    age, sex, and comorbidities.
Consequences of the disease
   Reducing the risk of death is one of the primary aims of AF man-
agement, and healthcare in general23. As such, annual assessment of
crude and risk-adjusted rates of all-cause mortality is recommended
                                                                             AF-related symptoms can be a useful subjective measure of both the
(indicator 06.1MQI1). Risk adjustment should, as a minimum, con-
                                                                             clinical consequences of AF and the success of rate- and rhythm con-
sider age, sex, and comorbidities. In addition, the inclusion of lifestyle
                                                                             trol treatment from the patients’ perspective. Using a validated
factors (e.g. smoking status, body mass index, physical activity, and al-
                                                                             method, such as the modified European Heart Rhythm Association
cohol intake) provides a better insight to the adjustment process.
                                                                             (EHRA) score121 is recommended to assess symptom status (indica-
Given that ischaemic stroke is a major complication of AF and, that
                                                                             tor 06.1SQI4).
most AF patients (CHA2DS2-VASc score of >_1 in men and >_2 in
women) will be eligible for stroke prevention, the overall and risk-
adjusted annual incidence of stroke and, separately, transient ischae-
mic attack should be recorded as a QI (indicator 06.1MQI2). Other            Complications of treatment
outcomes measures, which may provide an illustration of the quality          OAC treatment conveys an increased risk of major bleeding.
of AF care, include the rate of cardiovascular mortality (indicator          However, bleeding complications can also occur in the absence of
06.1SQI1), cardiovascular hospitalization (indicator 06.1SQI2), over-        OAC treatment122. The incidence of life-threatening or major bleed-
all thrombo-embolic events (indicator 06.1SQI3), and clinician-              ing events, defined by the International Society of Thrombosis and
reported AF symptom status (indicator 06.1SQI4).                             Haemostasis criteria123,124, should be reported annually as a QI (indi-
   In the ABC pathway of AF management mentioned earlier, the ‘B’            cator 06.2MQI1). The annual rate of haemorrhagic stroke is of partic-
component pertains to ‘better’ symptom management33. Many AF                 ular importance (indicator 06.2SQI1) and should be documented as
patients may not be overtly symptomatic. However, assessment of              a QI.
Quality indicators for the care and outcomes of adults with atrial fibrillation                                                              Page 11 of 17

06.2MQI1: Annual rate of life-threatening or major bleeding                       06.3MQI1: Proportion of patients with health-related quality of
events&                                                                           life assessment
Numerator: Number of patients with AF on anticoagulation who had                  Numerator: Number of patients with AF who have their health-related
documented life-threatening or major bleeding events during the mea-              quality of life assessed at the time of diagnosis and least annually after-
surement duration.                                                                wards using a validated instrument.
Denominator: Number of patients with AF on anticoagulation.                       Denominator: Number of patients with AF.
06.2MQI2: Annual rate of procedure-related&& 30-day                               06.3SQI1: Proportion of patients with patient-reported symp-

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mortality                                                                         tom status assessment
Numerator: Number of patients with AF who died due to an invasive                 Numerator: Number of patients with AF who have their patient-
procedure for AF management during the measurement duration.                      reported symptom status assessed at the time of diagnosis and least an-
Denominator: Number of patients with AF treated with invasive                     nually afterwards using a validated instrument.
procedures.                                                                       Denominator: Number of patients with AF.
06.2MQI3: Annual rate of procedure-related&& major compli-                        06.3SQI2: Proportion of patients with physical function
cations or drug-related serious adverse events$                                   assessment
Numerator: Number of patients with AF who had documented major                    Numerator: Number of patients with AF who have their physical func-
procedural complications and/or drug-related serious adverse events               tion assessed at the time of diagnosis and at every follow-up appointment
during the measurement duration.                                                  using a validated instrument.
Denominator: Number of patients with AF.                                          Denominator: Number of patients with AF.
06.2SQI1: Annual rate of haemorrhagic stroke                                      06.3SQI3: Proportion of patients with emotional well-being (in-
Numerator: Number of patients with AF who had documented haemor-                  cluding anxiety and depression) assessment
rhagic stroke during the measurement duration.                                    Numerator: Number of patients with AF who have their emotional
Denominator: Number of patients with AF on anticoagulation.                       well-being (including anxiety and depression) assessed at the time of diag-
                                                                                  nosis and at every follow-up appointment using a validated instrument.
                                                                                  Denominator: Number of patients with AF.
                                                                                  06.3SQI4: Proportion of patients with cognitive function
                                                                                  assessment
    AF procedure-related deaths occurring within the first 30 days fol-           Numerator: Number of patients with AF who have their cognitive func-
lowing catheter-based ablation, surgical ablation procedure, hybrid               tion assessed at the time of diagnosis and at least annually afterwards us-
catheter and surgical ablation, left atrial appendage closure/occlusion           ing a validated instrument.
(device), left atrial appendage ligation/excision (surgical), electrical          Denominator: Number of patients with AF.
cardioversion, or pacemaker implantation, should be reported annu-
ally as a QI (indicator 06.2MQI2). Furthermore, any procedure-
related major complication or drug-related serious adverse event,
defined as any untoward medical occurrence that results in death,                 life (AFEQT) or the Atrial Fibrillation Severity Scale (AFSS)]131–134.
life-threatening outcomes, hospitalization (initial inpatient hospitaliza-        Both the SF-12 and the AFEQT are validated, psychometrically ro-
tion or prolongation of existing hospitalization for >_24 h), or perma-           bust assessments of HRQoL, and are recommended by the
nent injury, should be reported in real-time according to local or                International Consortium of Healthcare Outcome Measures
national policy, and annually as a marker of quality (indicator                   (ICHOM) for AF135. Regardless of which validated tool is employed,
06.2MQI3). Although a single QI is suggested for procedural compli-               it is important that the same PROM is used consecutively to assess
cations (e.g. atrio-oesophageal fistula, cardiac tamponade, PV steno-             HRQoL to permit temporal comparison of scores and allow the de-
sis, phrenic nerve palsy, etc.), and drug-related adverse events (e.g.            termination of response to treatment.
arrhythmias, sudden cardiac death, etc.), individual events may be col-               Determining the impact of AF and its treatment on the patient are
lected in each centre for local monitoring and between-centre                     important considerations in the management of AF and may contrib-
comparisons.                                                                      ute to patient and healthcare provider decisions regarding continua-
                                                                                  tion/cessation of certain treatments and/or initiating alternatives. In
                                                                                  addition to HRQoL, the assessment of other PROMs, such as
Patient-reported outcomes                                                         patient-reported symptom status (indicator 06.3SQI1), physical func-
PROMs are important determinants of the patients’ perceived                       tioning (indicator 06.3SQI2), emotional well-being (indicator
quality and success of treatment125–127. The 2020 ESC Guidelines                  06.3SQI3), and cognitive function (indicator 06.3SQI4), could also be
recommend that patient-reported outcomes should be routinely                      considered. The assessment of HRQoL, patient-reported symptom
collected to measure treatment success and improve patient                        status, physical functioning, and emotional well-being is recom-
care23. Health-related quality of life (HRQoL) is considered the                  mended at baseline and once to twice annually, while the assessment
main QI and should be assessed at baseline and at follow-up visits                of cognitive function is recommended at baseline and annually there-
(indicator 06.3MQI1).                                                             after, given that it may show little variation over a shorter period of
   Several validated tools are available to measure general HRQoL128              time. Validated tools, such as those recommended by the ICHOM
[e.g. the Short-Form 12 (SF-12)]129, while others specifically measure            for AF135 (PROMIS Global Health for physical and emotional well-
AF-specific HRQoL130 [e.g. the Atrial Fibrillation Effect on QualiTy of           being, and PROMIS for cognitive function) can be used.
Page 12 of 17                                                                                                                       E. Arbelo et al.

Comparison with other quality metrics                                      behaviour and practice, and were not included in the final set of indi-
Table 4 shows a comparison between the 2020 ESC QIs for AF and             cators. Other QIs, such as the reintroduction of OAC after a severe
quality metrics from other professional organizations, such as the         bleeding event, once the condition leading to the bleeding event has
American College of Cardiology and the American Heart                      been appropriately addressed59,157, and the use of strict versus le-
Association (ACC/AHA), the National Institute for Health and Care          nient rate control treatment158, were proposed in the initial set of
Excellence (NICE), the Canadian Cardiovascular Society (CCS), and          candidate QIs, but were deemed difficult to operationalize, and, thus,
ICHOM. There are major differences between the process QIs pro-            were not included.

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posed here, and those developed by ACC/AHA, NICE, and CCS.                    Conversely, and to emphasize that improving outcomes is the ulti-
These differences may be explained by the variation in clinical prac-      mate aim of a quality of care assessment (Figure 1), particular atten-
tice guidelines endorsed by different societies and/or local needs to      tion was given to outcome QIs. The term ‘outcome measures’ was
address certain gaps in AF care. Outcome QIs were relatively similar       used separately and in different variations in the systematic review
compared to those proposed by ICHOM.                                       search strategy (APPENDIX 3). The outcome QIs selected are appli-
                                                                           cable to all domains of AF care, and are in line with the recent
                                                                           ICHOM recommendations159.
Discussion                                                                    One important type of outcome QIs is PROMs, which are increas-
                                                                           ingly used in everyday practice. Although a structured methodology
Evaluating the quality of care delivered and measuring meaningful          for developing and reporting PROMs exists159, there is uncertainty
outcomes of both the condition and its treatment have become an            around the best instruments to collect such measures. By defining
essential element of modern healthcare136. AF is the most common           specific PROMs and recommending tools for their measurement, the
cardiac arrhythmia, affecting 2–4% of the population, and is a major       Working Group hopes to promote PROMs use in a systematic man-
cause of significant morbidity137. Although evidence suggests that ad-     ner. However, developing outcome QIs to measure the results of
herence to guideline-recommended therapies for AF is associated            PROMs assessment, as well as their temporal trends may not be fea-
with improved outcomes138,139, data from AF registries continue to         sible in contemporary practice. Thus, process QIs to measure and en-
show room for improvement and significant geographical variation in        courage PROMs assessment were developed instead.
AF quality of care and outcomes57,58,140–153. QIs have been devel-            The Working Group acknowledges that high-quality evidence sup-
oped to evaluate the quality of AF care18,20,21,154,155. Furthermore,      porting PROMs use is limited, widely accepted tools to collect them
QIs provide the mechanism to assess the effectiveness of quality im-       are lacking, and little experience exists on how PROMs can guide AF
provement initiatives156. However, standardized measures to facili-        treatment decisions. The same argument can be levelled at shared
tate ongoing efforts to quantify the adherence to guidelines are           decision making in AF management. However, these aspects of AF
needed.                                                                    care were deemed essential by the Working Group, thus QIs for
   The present document is the first effort undertaken by the ESC to       PROMs and shared decision making were developed.
develop a set of QIs to assess the quality of care for patients with AF.      The patient’s perspective is a fundamental element of optimal AF
Using the ESC methodology for QIs development24, we have estab-            care given that most therapies are aimed at improving patients’ symp-
lished a comprehensive set of QIs for AF care, which are supported         toms, well-being, and overall QoL. Measuring patient-centred out-
by evidence and underpinned by expert consensus. Thus, they pro-           comes in a standardized way may allow comparison of performance,
vide tools to quantify the quality of AF care and can be used as a basis   enable clinicians to learn from each other, and improve the care we
for quality improvement. The simultaneous development of the ESC           provide to our patients. However, further validation of the tools and
AF QIs and the ESC Clinical Practice Guidelines for AF facilitated         methods used to collect the patient’s perspective in routine clinical
seamless incorporation of QIs within the guidelines document. As           practice is needed. As such, these tools may be used to guide the de-
such, a summary form of the developed QIs is embedded within the           velopment of, and the effect of, treatment strategies for AF patients.
ESC Clinical Practice Guidelines for AF, with the hope of enhancing           The methodology used for the selection of QIs has limitations. We
their dissemination and, therefore, uptake into clinical practice23.       relied on expert opinion to arrive at the final set of QIs following the
   This document is the result of an international collaboration (12       comprehensive systematic review of the literature. A different panel
countries) from seven professional societies/associations with a           of experts may have selected different QIs. We addressed this chal-
Working Group consisting of a wide range of stakeholders, including        lenge by using the modified Delphi method, and by involving AF spe-
patients. In addition, the application of ESC criteria ensured that de-    cialists with different areas of expertise, as well as patients and
veloped QIs are not only based on evidence, but also cover broad           representatives from AF patient associations.
aspects of AF care where there is a gap in care delivery, potential for       Another challenge is that, if considered in isolation, QIs may cause
quality improvement, and the availability of reliable data collection      some unintended consequences, such as anticoagulation prescription
sources. To that end, different types of QIs including structural, pro-    for patients with very high bleeding risk or recommending catheter
cess, and outcome indicators26 were included in the initial set of can-    ablation for frail patients with major risk factors for AF recurrence.
didate QIs.                                                                We have sought to circumvent this issue by clearly defining eligible
   The Working Group, however, considered structural QIs, such as          patients for each QI and specifying relevant exclusions. The suggested
the volume of catheter ablation cases for centres and individual oper-     QIs are intended to drive holistic patient assessments and tailor treat-
ators not to be directly under the control of healthcare providers.        ments to individual patients to improve patient care. More refine-
Thus, structural QIs, although important, were given less priority         ment of these QIs and/or their definitions may be needed in the
compared with other process QIs that may influence providers’              future when more ‘real-world’ and feasibility data become available.
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